Reanalysis for Pharmacokinetic Reason [Bioanalytics]

posted by Obinoscopy  – USA, 2020-07-16 14:30 (375 d 11:07 ago) – Posting: # 21713
Views: 3,552

Dear All,

I am trying to get my head around why reanalyzing a blank sample because it had values above LLOQ in the initial analysis is not considered reanalysis for pharmacokinetic reason.

My thinking is...if a pre-dose sample gives a detectable peak area on analysis and on evaluation, there seem to be no explanation for this, why is it okay to reanalyze it again? Isn't it not considered reanalysis based on PK? Could it be because the concentration at time t = 0 is not used in calculating AUC? I don't know.

Also please what are the examples of reanalysis that are considered reanalysis due to PK reasons?

Thanks.

Scopy

Complete thread:

Activity
 Admin contact
21,589 posts in 4,512 threads, 1,530 registered users;
online 4 (0 registered, 4 guests [including 4 identified bots]).
Forum time: Tuesday 01:38 CEST (Europe/Vienna)

The great tragedy of Science – the slaying
of a beautiful hypothesis by an ugly fact.    Thomas Henry Huxley

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5